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FDA
Chimes in on Drug-Eluting Stents |
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September 14, 2006 -- Responding to the studies presented at the annual World Congress of Cardiology meeting in Barcelona last week, showing potential long term problems with drug-eluting stents, the U.S. Food and Drug Administration has announced that it "will convene a public meeting of the Circulatory System Devices Advisory Panel" by the end of the year to discuss these data. The panel will include "outside experts" to "assist the agency in the review and analysis of the available scientific data and provide recommendations for appropriate actions to address this issue, such as possible changes to device labeling or the need for additional clinical studies." The current FDA-required labeling for the device manufacturers, in a document known at the "Directions For Use", or DFU, calls for only 3 months of antiplatelet therapy after stent implantation for Cordis / Johnson & Johnson's Cypher stent and 6 months for Boston Scientific's Taxus stent. Few interventional cardiologists currently adhere to the minimum -- most now prescribe at least one year of clopidogrel (Plavix) and aspirin therapy. Several cardiologists, interviewed by Angioplasty.Org, feel that until more data has been accumulated, they will recommend an extended course of antiplatelet therapy, possibly for life in the appropriate patient. Although late stent thrombosis (blood clot) occurs in a small percentage of cases, when it does, it can cause a heart attack. It has been estimated that stent thrombosis is fatal one-third of the time. In reaction to the European studies, Angioplasty.Org has posted a "patient advisory" to help guide patients who have had or who about to have a drug-eluting stent implanted.
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